深化战略合作关系！药明生物助力北海康成领跑罕见病领域
CANbridge Pharmaceutical and WuXi Biologics Enter into Strategic Partnership for Rare Disease Therapeutics
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-北海康成计划于2019年在中国递交首个开发适应症的临床试验申请
全球领先的开放式生物制药技术平台公司药眀生物（2269.HK）与北海康成共同宣布深化战略合作关系，助力北海康成加速推进罕见病治疗药物研发管线的开发和商业化进程。此次合作将充分发挥药眀生物在生物药发现、开发和生产上的领先能力以及北海康成在注册及药政事务、临床开发和商业运营方面的优势。
此次双方强强联手得益于药明生物多年积累的新药发现和筛选服务能力，以及北海康成团队运作罕用药、孤儿药的成功经验。北海康成计划于2019年在中国递交首个开发适应症的临床试验申请，同时根据独占许可协议，北海康成将针对全球市场开发这些药物。药明生物则将获得开发项目的预付款、里程碑付款和全球销售提成。
北海康成创始人，董事长兼首席执行官薛群博士表示，“这一历史性的合作是罕见病药物开发进程的分水岭事件。我们深信这是两家具有前瞻性公司的完美合作。这一合作不仅能改变中国的罕见病药物开发进程，还会对全球的罕见病药物开发产生深远影响。”
“目前中国罕见病诊断和治疗领域存在大量未被满足的临床需求，我对北海康成勇于开拓这一令人激动的领域感到非常振奋。”药眀生物首席执行官陈智胜博士表示，“凭借全球合作伙伴认可的强大生物制药技术能力及全球首屈一指的产能规模，药明生物正在变革全球生物药的开发和生产进程。我们很高兴通过此次合作进一步赋能北海康成，助力其成为罕见病领域的领跑者，为更多中国患者提供亟需的创新疗法。”
关于药明生物
药明生物（股票代码：2269.HK）作为一家香港上市公司，是全球领先的开放式、一体化生物制药能力和技术赋能平台。公司为全球生物制药公司和生物技术公司提供全方位的端到端研发服务，帮助任何人、任何公司发现、开发及生产生物药，实现从概念到商业化生产的全过程，加速全球生物药研发进程，降低研发成本，造福病患。截至2018年6月30日，在药明生物平台上研发的综合项目达187个，包括98个处于临床前研究阶段，78个在临床早期（I期，II期）阶段，10个在后期临床（III期）以及1个在商业化生产阶段。预计到2021年，公司在中国、爱尔兰、新加坡、美国规划的生物制药生产基地合计产能约22万升，这将有力确保公司通过健全强大的全球供应链网络为客户提供符合全球质量标准的生物药。如需更多信息，请访问：www.wuxibiologics.com.cn。
关于北海康成
北海康成是一家位于中国的新药创制公司，专注于开发实体肿瘤特药和罕见病药物，这些领域存在大量未被满足或急需的临床需求。
北海康成是中国罕见病领域的领跑者，也是中国罕见病联盟的发起单位。与药明生物达成战略合作，合力推动罕见病药物的开发进程。与Puma Biotechnology（纳斯达克代码: PBYI）签署了NERLYNX®在中国大陆、台湾、香港和澳门进行开发和商业化的独占许可协议。与德国APOGENIX签署在大中华区研发和商业运营APG101的独家技术转让协议。与美国AVEO Oncology签署肿瘤ErbB3抑制性单抗药物AV203的全球（北美除外）的生产、研发及上市的独占许可协议。与英国EUSA Pharma签署Caphsol®在中国市场化权力的独占许可协议，Caphosol®用于治疗因放疗或高剂量化疗引起的口腔黏膜炎并在中国获批上市。如需更多关于北海康成的信息，请前往：www.canbridgepharma.com。
CANbridge Pharmaceutical and WuXi Biologics Enter into Strategic Partnership for Rare Disease Therapeutics
BEIJING, SHANGHAI, October 23, 2018
-CANbridge Plans to Submit First Rare Disease IND in China in 2019
CANbridge Pharmaceutical Inc., a biopharmaceutical company developing innovative drug candidates to treat underserved medical conditions in China and other markets, and WuXi Biologics (2269. HK), a leading global open-access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing, jointly announced today a strategic partnership to enable CANbridge to develop and commercialize a portfolio of biotherapeutics for the treatment of rare diseases. This partnership leverages WuXi Biologics’ drug discovery, development and manufacturing capabilities and CANbridge’s clinical, regulatory and commercial leadership.
This agreement builds on years of new product discovery capabilities established at WuXi Biologics, and the CANbridge team’s years of experience with orphan drug approval processes. As a result, CANbridge expects to file the first Investigational New Drug (IND) application in a rare disease in China with the lead candidate from this program in 2019. CANbridge may also develop these therapeutics on a global basis going forward under an exclusive licensing agreement. WuXi Biologics is expected to receive upfront payments, milestone payments and royalties on global sales for these programs.
“This historic partnership marks a watershed event in the development of therapeutics for patients with rare diseases,” said James Xue, PhD, Founder, Chairman and CEO, CANbridge Pharmaceutical Inc.“We believe it is a perfect marriage between two forward-thinking organizations and has the potential to change the world of rare disease dramatically in China, as well as globally.”
“There are huge unmet medical needs in China regarding rare disease diagnosis and treatment,” said Dr. Chris Chen, CEO of WuXi Biologics. “I am thrilled that CANbridge will be a trailblazer in this exciting field in China. Being globally recognized for leading technical capabilities, and unparalleled capacities in biologics discovery, development and manufacturing, we are excited to enable CANbridge to become a leader in rare diseases and to collaborate with them to bring the much-needed treatments to Chinese patients.”
About WuXi Biologics
WuXi Biologics (stock code: 2269.HK), a Hong Kong-listed company, is the only open-access biologics technology platform in the world offering end-to-end solutions to empower organizations to discover, develop and manufacture biologics from concept to commercial manufacturing. Our company history and achievements demonstrate our commitment to providing a truly ONE-stop service offering and value proposition to our global clients. As of June 30, 2018, there were a total of 187 integrated projects, including 98 projects in pre-clinical development stage, 78 projects in early-phase (phase I and II) clinical development, 10 projects in late-phase (phase III) development and 1 project in commercial manufacturing. With total estimated capacity of biopharmaceutical production planned in China, Ireland, Singapore and US reaching 220,000 liters by 2021, we will provide our biomanufacturing partners with a robust and premier-quality global supply chain network. For more information on WuXi Biologics, please visit www.wuxibiologics.com.
About CANbridge Pharmaceutical Inc.
CANbridge Pharmaceutical Inc. is a China-based bio-pharmaceutical company accelerating development and commercialization of specialty healthcare products for orphan diseases and targeted cancers, focusing on products that are unavailable or address medical needs that are underserved in the region.
CANbridge has been widely recognized as a leader in orphan diseases in China, and has a partnership with WuXi Biologics to develop and commercialize proprietary therapeutics for the treatment of rare diseases. CANbridge also has exclusive rights to develop and commercialize Puma Biotechnology’s NERLYNX® (neratinib) in China, Taiwan, Hong Kong and Macao (collectively, greater China); a license with Apogenix to develop and commercialize APG101 in greater China; a license (ex-North America) to develop and commercialize AVEO Oncology’s ErbB3 (HER3) inhibitory antibody candidate AV203 and an agreement with EUSA Pharma to commercialize Caphosol® for the prevention and treatment of oral mucositis caused by cancer treatments, for which it has received approval in China.
For more on CANbridge Pharmaceutical Inc., please go to www.canbridgepharma.com.
注：本信息不构成药明生物的信息披露或投资建议
